Method and machine for making uniform products

ABSTRACT

A method of forming an oral product includes gripping a rod of oral product material with a gripping device, indexing the rod forward to have a leading end of the rod abut a stop at a first location, cutting a leading portion of the rod to create an oral product, moving the stop to a second location to allow the oral product to fall, moving the stop back to the first location, and repeating the process. A machine for forming an oral product can include a cutting device adapted to cut through a rod of plastic material, a stop spaced from the cutting device, the stop being adapted to be moved from a first location to a second location, a gripping device adapted to hold and index a rod towards the stop, and a load cell positioned to receive oral products cut from a rod by the cutting device.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. §119(e)to U.S. Application No. 61/791,337 filed Mar. 15, 2013. The priorapplication is incorporated herein by reference in its entirety.

TECHNICAL FIELD

This document relates to methods and machines for making uniformproducts.

BACKGROUND

Oral products providing flavor and/or one or more active ingredients arewell known. One such oral product is chewing gum (e.g., nicotine gum).Other oral products include hard candies (e.g., mints). Softergelatin-based oral products are also known. Pharmaceutical andtherapeutic products (e.g., cough-suppressant lozenges) can also beprovided in a solid form for oral consumption. Smokeless tobaccoproducts can also be provided in a number of different forms.

Having consistent product weights can be important for product safetyreasons and/or for labeling requirements. Having consistent dimensionscan also improve the appeal of manufactured products. A checkweigher canbe used to make sure that a product is of a desired weight. Acheckweigher is an automatic machine for checking the weight of aproduct or a packaged commodity. It is normally found at the offgoingend of a production process and is used to ensure that the weight of aproduct or package is within specified limits. Any products or packagesthat are outside the tolerance are taken out of line automatically.Having a process that consistently forms products of a consistent sizeand/or weight can reduce costs and by eliminating the production ofreject products.

SUMMARY

This specification provides methods and machines for forming oralproducts. In particular, the method can include gripping a rod of oralproduct material with a gripping device, indexing the rod forward tohave a leading end of the rod abut a stop at a first location, cutting aleading portion of the rod to create an oral product, moving the stop toa second location to allow the oral product to fall, moving the stopback to the first location, and repeating the process. A machine forforming an oral product can include a cutting device adapted to cutthrough a rod of plastic material, a stop spaced from the cuttingdevice, the stop being adapted to be moved from a first location to asecond location, a gripping device adapted to hold and index a rodtowards the stop, and a load cell positioned to receive oral productscut from a rod by the cutting device. In some cases, the machine caninclude an infeed tray to support the rod material. In some cases, themachine can include a drop tube for directing a cut oral product to theload cell. In some cases, the machine can include air nozzles to blowthe product off or out of the load cell and towards a collectionlocation or a discard location.

The rod of oral product material can be an extruded rod. The rod of oralproduct material can include one or more polymers and one or moreadditives dispersed in the one or more polymers. In some cases, the rodof oral product material can include nicotine, cellulosic fibers,sweetener, and flavorants dispersed in a polymer matrix (e.g.,polyurethane matrix). In some cases, the rod of oral product materialcan include tobacco dispersed in a polymer matrix (e.g., polyurethanematrix). In some cases, the rod of oral product material can be tobaccoand nicotine free. The rod can be at a temperature of below 50° C. whenplaced in a machine provided herein. The rod can have a variety ofcross-sectional shapes. The rod can have a uniform cross-sectionalshape. The rod can have a length of at least 5 times the largestdiameter of the rod. In some cases, the rod can have a length of atleast 1 meter, of at least 5 meters, or of at least 10 meters. Anextended infeed tray can be used to support the rod.

A gripping device can clamp down on the rod to ensure that it does notmove during a cutting operation. In some cases, multiple grippingdevices can be used. In some cases, a gripping device can include a pairof gripping rollers positioned on opposite sides of the rod. Grippingrollers can rotate to index the rod while gripping the rod. In somecases, a gripping device can include two gripping pads that clamp onopposite sides of the rod. Gripping pads can be moved from a firstgripping location to a second gripping location. In some cases, betweencutting operations, the gripping pads can become spaced from each otherto disengage from the rod at the second gripping location, move towardsto the first gripping location, grip the rod again at the first grippinglocation, and index back to the second location to index the rod. Insome cases, the rod advance mechanism may include a weighted guideroller or other device to hold the rod in position while the disengagedgripper moves from the second gripping location back to the firstgripping location. In some cases, a gripping device can include grippingrollers to index the rod and gripping pads that do not index back andforth relative to the cutting device, but merely engage the rod duringeach cutting operation.

A cutting device can include a cutting blade, a blade holder, a bladeholder guide, and a blade actuator to cut the product. A blade holderand a blade holder guide can be positioned to ensure that the bladeremains in a predetermined position relative to the stop so that eachoral product cut from the rod has a consistent thickness. The bladeactuator can be timed to ensure that the cutting operation does notbegin until the rod is fully indexed to abut the stop.

The stop provides a mechanical stop surface to ensure that a leading endof the rod is properly spaced from the cutting blade during a cuttingoperation. The stop can be an adjustable stop. In some cases, the stopcan include a micrometer head to allow for small adjustments. During acutting operation, the stop is positioned in a first location, butbetween cutting operations, the stop can be actuated to a secondlocation. Moving the stop to the second location permits the oralproduct to fall out of the way to permit the rod to be indexed again anda next oral product to be cut. In some cases, the stop is pivoted fromthe first location to the second location.

A drop tube can be provided below the cutting device to catch oralproducts as they fall from the cutting blade and/or stop surface. Insome cases, the drop tube can include a bottom door, which can beselectively actuated to drop one or more oral products to a load cell. Aload cell can weigh one or more oral products to ensure that they fallwithin a desired weight range. If an oral product, or group of oralproducts, is within a desired weight range, they can be transferred to acollection location. If an oral product, or group of oral products, isoutside of a desired weight range, they can be transferred to a discardlocation. In some case, air nozzles can blow the oral products to theappropriate location. In some cases, a star wheel can be used to directoral products to the appropriate location.

The details of one or more embodiments of the subject matter describedin this specification are set forth in the accompanying drawings and thedescription below. Other features, aspects, and advantages of thesubject matter will become apparent from the description, the drawings,and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of a machine/method used to cut oral productsfrom a rod of oral product material.

FIG. 2 is an illustration of a star wheel used to weigh and sort oralproducts cut from a rod or oral product material.

FIGS. 3A-3D illustrate an exemplary cutter assembly.

FIGS. 3E-3H illustrate an exemplary rotary weight station.

FIG. 4 is a perspective view of a pair of oral products.

FIGS. 5A-5L illustrate various exemplary shapes of oral products.

FIGS. 6A-6I are pictures of an exemplary machine used to cut oralproducts from a rod of oral product material.

DETAILED DESCRIPTION

Machines and methods for forming oral products are provided herein. Theoral products can include a mouth-stable polymer matrix and one or moreadditives. The additives can include flavorants, sweeteners, activeingredients, or any other suitable ingredient intended to be releasedfrom the oral product when the oral product is received within the oralcavity and exposed to saliva. The oral products can provide a favorableadditive release profile and tactile experience. The methods andmachines provided herein can reliably produce oral products have uniformdimensions.

The machine and methods provided herein reliably produce uniformlyshaped oral products at speeds of up to 100 cuts per minute per lane,with minimal or no material loss due to blade kerf, reduced manpower,and with accurate product weighing and classification of cut oralproducts. In some cases, a machine provided herein can provide speeds ofgreater than 50 cuts per minute per lane. The machine provided hereincan accurately cut a consistent thickness due to the placement of a stopat a spaced distance from a cutting blade and the use of grippingdevices to grip index a leading end of the rod to a position abuttingthe stop. The stop can move between a first location and a secondlocation that permits a cut oral product to freely fall out of the wayso that the rod can be indexed again to cut the next oral product. Theuse of the stop also allows for a blade that shears the rod with minimalor no kerf. The dropping of the piece to a load cell that automaticallyweighs one or more oral products can reduce the manpower needed tooperate the machine and eliminate human error in weighing andclassifying oral products.

FIG. 1 depicts an illustration of a machine/method for creating oralproducts. A rod 101 of oral product material (discussed in greaterdetail below) can be gripped by gripping rollers 120 a and 120 b and/orgripping pads 130 a and 130 b. In some cases, a machine can includegripping rollers without gripping pads, gripping pads without grippingrollers, or a combination of gripping rollers and gripping pads. In somecases, multiple pairs of gripping rollers can be used. In some cases,multiple pairs of gripping pads can be used. In some cases, an infeedtray 105 can be used to support the rod material. An infeed tray caninclude a long (e.g., 1 meter, 5 meters, 10 meters, or 25 meter) flatsurface. In some cases, an infeed tray can include multiple rollers thatrotate freely. The gripping rollers 120 a and 120 b and/or gripping pads130 a and 130 b can index the rod forward after each cut. The grippingrollers 120 a and 120 b and/or gripping pads 130 a and 130 b can clampdown on the rod to ensure that it does not move during a cuttingoperation. Gripping pads 130 a and 130 b can be moved from a firstgripping location 131 to a second gripping location 132. In some cases,between cutting operations, the gripping pads 130 a and 130 b can beseparated to be spaced from each other to disengage from the rod at thesecond gripping location 132, moved towards to the first grippinglocation 131, grip the rod again at the first gripping location 131, andindex back to the second location 132 to index the rod. In some cases, agripping device can include gripping rollers 120 a and 120 b to indexthe rod and gripping pads 130 a and 130 b that do not index back andforth relative to the cutting device, but merely engage the rod duringeach cutting operation.

A cutting device can include a cutting blade 140, a blade holder 141, ablade holder guide 142, and a blade actuator (not shown) to cut an oralproduct 110 from the rod 101. A blade holder 141 and a blade holderguide 142 can be positioned to ensure that the blade remains in apredetermined position relative to the stop so that each oral product110 cut from the rod 101 has a consistent thickness. The blade actuatorcan be timed to ensure that the cutting operation does not begin untilthe rod is fully indexed to abut the stop.

The stop 150 provides a mechanical stop surface to ensure that a leadingend of the rod 101 is properly spaced from the cutting blade 140 duringa cutting operation. The stop can be an adjustable stop. In some cases,the stop can include a micrometer head to allow for small adjustments.During a cutting operation, the stop is positioned in a first location156, but between cutting operations, the stop can be actuated to asecond location 157 (shown in dotted lines 152). Moving the stop to thesecond location permits the oral product 110 to fall out of the way topermit the rod 101 to be indexed again and a next oral product 110 to becut. In some cases, the stop is pivoted from the first location 156 tothe second location 157 about a pivot 154.

A drop tube 148 can be provided below the cutting device to catch oralproducts 110 as they fall from the cutting blade 140 and/or stop surface151. In some cases, the drop tube 148 can include a bottom door 147 witha hinge 149, which can be selectively actuated to drop one or more oralproducts to a load cell 160. A load cell 160 can weigh one or more oralproducts 110 to ensure that they fall within a desired weigh range. Insome cases, a plurality of oral products 110 can be weighed at once tosee if the sum of their weight is within a desired range for that numberof oral products 110. For example, ten oral products could be weighed atonce to determine if those oral products are, on average, within thedesired weight range. If an oral product, or group of oral products, iswithin a desired weight range, they can be transferred to a collectionlocation 173. If an oral product, or group of oral products, is outsideof a desired weight range, they can be transferred to a discard location171. In some case, air nozzles 170 and 172 can blow the oral products tothe appropriate location.

FIG. 2 illustrates a star wheel 180, which can be used to help weigh andclassify one or more oral products 110. As shown, a rod 101 can be cutwith a cutting blade 140 using a stop 150 as discussed above. The oralproduct 110 can drop into a drop tube 148, which can direct the oralproduct 110 to a recess in a first position 182 of a star wheel. Afterone or more oral products fall into the recess at the first position182, the star wheel can rotate to move the one or more oral products toa second position 184 over a load cell 160. The load cell 160 can weighthe oral product(s) and classify wither the oral product(s) are within apredetermined range. The star wheel can then move to a third position186, which is positioned over a trap door 174. Trap door 174 can beselectively open or closed depending on the classification of those oralproducts based on the weigh reading of the load cell. For example, ifthe oral product(s) are within range, the trap door 174 can be opened toallow for the oral product(s) 110 to fall to a collection location. Ifthe oral product(s) are outside of the predetermined range, the trapdoor 174 can be closed so that the oral product(s) are moved to fourthposition 188 when the star wheel 180 next rotates and fall though hole175 to a discard location.

FIGS. 3A-3D illustrate an exemplary cutter assembly 300 for cutting arod into a plurality of oral products. As shown, the assembly caninclude an infeed tray 305. A guide roller 320 can be used to ensure aproper alignment of the rod as it advances. Gripping pads 330 a and 330b can clamp on the sides of a rod being advanced through the cutterassembly 300. As shown in FIG. 3C, the cutter assembly 300 can include agripper actuator 334 that can cause the gripping pads 330 a and 330 b toclamp together or release. In some cases, the gripping pads 330 a and330 b can grip a rod and move to advance the rod through the cutterassembly 300. As shown in FIG. 3C, the cutter assembly 300 can include agripper advance actuator 332 that can cause the gripping pads 330 a and330 b move back and forth relative to the blade, which can be used tointermittently advance the rod between cutting operations.

A rod being advanced will have a leading end abut an adjustable stop350. Between cutting operations, the adjustable stop 350 can be pivotedabout stop pivot 352 by stop actuator 354. A micrometer head 356 can beused to make small and precise adjustments to the placement of theadjustable stop 350. The rod is cut by a cutting blade in a blade holder341 guided by a blade holder guide 342 and actuated by blade actuator344.

FIGS. 3E-3H illustrates a rotary weigh station, which can be used toweigh and classify one or more oral products in a manner similar to thatdescribed above in reference to FIG. 2. Oral products can drop into oneof cells at position 381, 382, or 383 in wheel 380. Wheel 380 canincrementally rotate after a predetermined number of products fall intoa given cell (e.g., a cell at position 381). After rotation through oneor more increments, the product(s) in a given cell will eventually moveinto position 383, where the product(s) are weighed by weigh scale 360.A programmable logic controller, which can include memory, can thenstore the weight or a classification for the product(s) in that cell andassociate that with that cell to control whether those products are sentto a waste chute 378 or to a good products chute 376. The product(s) ina given cell will then move as the wheel 380 is rotated trough positions384 and 385 to position 386, which is positioned over a trap door 374.Based on the stored weight or classification of the product(s) in thecell, the programmable logic controller can open or close trap door 374.If the product(s) is/are in a predetermined weight range, trap door 374will open to allow the product(s) to fall into the good product chute376. If the product(s) is/are outside of a predetermined weight range,trap door 374 will be closed to allow the product(s) to in the cell toadvance past position 386 to position 387. As the wheel 380 continues torotate, reject products will pass through positions 387, 388, and 389,and eventually reach the waste chute 378 at position 390.

FIGS. 6A-6I are pictures of an exemplary machine provided herein. FIG.6A depicts a rear view of a machine including three lines, each havingan infeed tray. FIG. 6B depicts a front view of this same machine. Asshown, each line includes a cutting device, a stop, a load cell. FIG. 6Cis a side view showing a guide roller, gripping pads, a blade guide, andan adjustable stop actuator. FIG. 6D shows a guide roller, grippingpads, a blade holder, and a blade guide. FIG. 6E shows a blade actuator,a blade guide, gripping pads, and a guide roller. FIG. 6F shows theadjustable stop engaged by a rod. FIG. 6G shows the adjustable stop, thecutting blade, the blade holder, and the gripping pads engaged with therod. FIG. 6H shows the adjustable stop retracted to a second position sothat a cut oral product can fall away from the cutting blade. FIG. 6Ishows a drop tube, a bottom door of the drop tube, a load cell pan, andblow off nozzles.

Oral Product Shapes and Packaging

FIG. 4 depicts an example of an oral product 410. The oral product 410has a disk shape. For example, the oral product 410 can have a diameterof about 12 mm and a thickness of about 2.5 mm. The oral products can bemolded into any other desired shape. For example, referring to FIGS.5A-5L, the oral product 410A-L can be formed in a shape that promotesimproved oral positioning in the oral cavity, improved packagingcharacteristics, or both. In some circumstances, the oral product 410A-Lcan be configured to be: (A) an elliptical-shaped oral product 410A; (B)an elongated elliptical-shaped oral product 410B; (C) semi-circular oralproduct 410C; (D) square or rectangular-shaped oral product 410D; (E)football-shaped oral product 410E; (F) elongated rectangular-shaped oralproduct 410F; (G) boomerang-shaped oral product 410G; (H) rounded-edgerectangular-shaped oral product 410H; (I) teardrop- or comma-shaped oralproduct 410I; (J) bowtie-shaped oral product 410J; (K) peanut-shapedoral product 410K; and (L) shield-shaped oral product 410L.

One or more oral products 410 or 410A-L can be packaged in a variety ofconventional and non-conventional manners. For example, a plurality oforal products 410 or 410A-L can be packaged in a container having a lid.In some cases, a plurality of oral products 410 or 410A-L can be stackedand packaged in a paper, plastic, and/or aluminum foil tube. Thepackaging can have a child-resistant lid. The oral product 410 or 410A-Lcan also include additional elements. In some cases, a mouth-stablepolymer matrix including nicotine or a derivative thereof can beattached to a rod, tube, or stick.

Other Materials

The extrudate and thus the resulting oral products 410 or 410A-L includeat least one polymer and one or more additives. The additives can beflavorants, sweeteners, active ingredients, or any other substanceintended to be released when placed within a mouth. The ingredientslisted below are merely illustrative and non-limiting.

Polymers

In some cases, the polymer can be a mouth-stable polymer. Suitablemouth-stable polymers include thermoplastic elastomers such aspolyurethane. As used here, the term “mouth stable” means that thepolymer does not appreciably dissolve or disintegrate when exposed tosaliva within an oral cavity and at the normal human body temperature(e.g., about 98.6° F.) over a period of one hour. In addition tobiostable polymers, mouth-stable polymers can include biodegradablepolymers that breakdown over periods of days, weeks, months, and/oryears, but do not appreciably break down when held in an oral cavity andexposed to saliva for a period of one hour. In some cases, themouth-stable polymer is stable within an oral cavity and exposed tosaliva at the normal human body temperature for a period of at least 6hours, at least 12 hours, at least 24 hours, or at least 2 days.Accordingly, the oral products described herein can remain intact whenplaced within an oral cavity during a use period. After use, themouth-stable polymer matrix can be removed from the oral cavity anddiscarded.

The mouth-stable polymer can be a variety of different biocompatible andbiostable polymers. In some cases, the mouth-stable polymer is a polymergenerally recognized as safe by an appropriate regulatory agency. Insome cases, the polymer is a thermoplastic polymer. The polymer can alsobe a thermoplastic elastomer. For example, suitable mouth-stablepolymers include polyurethanes, silicon polymers, polyesters,polyacrylates, polyethylenes, polypropylenes, polyetheramides,polystyrenes (e.g., acrylonitrile butadiene styrene, high impactpolystyrenes (HIPS)) polyvinyl alcohols, polyvinyl acetates, polyvinylchlorides, polybutyl acetates, butyl rubbers (e.g., polyisobutylenes),SEBS, SBS, SIS, and mixtures and copolymers thereof. In some cases, themouth-stable polymer is food-grade or medical-grade polymers (e.g.,medical-grade polyurethane).

The mouth-stable polymer forms the mouth-stable polymer matrix of theextrudate and the resulting oral products 410 or 410A-L. In some cases,the extrudate includes at least 10 weight percent of one or moremouth-stable polymers. In some cases, the extrudate includes at least 20weight percent, at least 30 weight percent, at least 40 weight percent,at least 50 weight percent, at least 60 weight percent, at least 70weight percent, at least 80 weight percent, or at least 90 weightpercent of one or more mouth-stable polymers. In some cases, theextrudate includes between 10 and 90 weight percent of one or moremouth-stable polymers. Accordingly to some embodiments, the extrudateincludes between 40 and 80 weight percent of the mouth-stable polymers.

The mouth-stable polymer according to certain embodiments has a flexuralmodulus of at least 5 MPa when tested according to ASTM Testing MethodD790 or ISO 178 at 23 degrees Celsius. In some cases, the flexuralmodulus is at least 10 MPa. For example, the flexural modulus can bebetween 10 MPa and 30 MPa. In some cases, the mouth-stable polymer is agrade that complies with food-contact regulations applicable in one ormore countries (e.g., US FDA regulations). In some cases, themouth-stable polymer can be a polyurethane, SIS, or other thermalplastic elastomer meeting the requirements of the FDA-modified ISO10993, Part 1 “Biological Evaluation of Medical Devices” tests withhuman tissue contact time of 30 days or less. The mouth-stable polymercan have a shore Hardness of 50D or softer, a melt flow index of 3 g/10min at 200° C./10 kg, a tensile strength of 10 MPa or more (using ISO37), and a ultimate elongation of less than 100% (using ISO 37).

Additives

A variety of additives can be included in the extrudate. The additivescan include alkaloids (e.g., caffeine, nicotine), minerals, vitamins,dietary supplements, nutraceuticals, energizing agents, soothing agents,coloring agents, amino acids, chemesthetic agent, antioxidants, foodgrade emulsifiers, pH modifiers, botanicals (e.g., green tea), teethwhitening (e.g., SHRIMP), therapeutic agents, sweeteners, flavorants,and combinations thereof. In some cases, the additives include nicotine,sweeteners, and flavorants. In some cases, the nicotine can be tobaccoderived nicotine. With certain combinations of nicotine, sweeteners, andflavorants, the oral product may provide a flavor profile and tactileexperience similar to certain tobacco products.

The extrudate can also include one or more antioxidants. Antioxidantscan result in a significant reduction in the conversion of nicotine intonicotine-N-oxide when compared to oral products without antioxidants. Insome cases, the extrudate can include 0.01 and 5.00 weight percentantioxidant, between 0.05 and 1.0 weight percent antioxidant, between0.10 and 0.75 weigh percent antioxidant, or between 0.15 and 0.5 weightpercent antioxidant. Suitable examples of antioxidants include ascorbylpalmitate (a vitamin C ester), BHT, ascorbic acid (Vitamin C), andsodium ascorbate (Vitamin C salt). In some cases, monosterol citrate,tocopherols, propyl gallate, tertiary butylhydroquinone (TBHQ),butylated hydroxyanisole (BHA), Vitamin E, or a derivative thereof canbe used as the antioxidant. For example, ascorbyl palmitate can be theantioxidant in the formulations listed in Table I. Antioxidants can beincorporated into the polymer (e.g., polyurethane) during the extrusionprocess.

A variety of synthetic and/or natural sweeteners can be in theextrudate. Suitable natural sweeteners include sugars, for example,monosaccharides, disaccharides, and/or polysaccharide sugars, and/ormixtures of two or more sugars. According to some embodiments, theextrudate includes one or more of the following: sucrose or table sugar;honey or a mixture of low molecular weight sugars not including sucrose;glucose or grape sugar or corn sugar or dextrose; molasses; cornsweetener; corn syrup or glucose syrup; fructose or fruit sugar; lactoseor milk sugar; maltose or malt sugar or maltobiose; sorghum syrup;mannitol or manna sugar; sorbitol or d-sorbite or d-sorbitol; fruitjuice concentrate; and/or mixtures or blends of one or more of theseingredients. The extrudate can also include non-nutritive sweeteners.Suitable non-nutritive sweeteners include: stevia, saccharin; Aspartame;sucralose; or acesulfame potassium.

The extrudate can optionally include one or more flavorants. Theflavorants can be natural or artificial. For example, suitableflavorants include wintergreen, cherry and berry type flavorants,various liqueurs and liquors (such as Drambuie, bourbon, scotch, andwhiskey) spearmint, peppermint, lavender, cinnamon, cardamom, apiumgraveolents, clove, cascarilla, nutmeg, sandalwood, bergamot, geranium,honey essence, rose oil, vanilla, lemon oil, orange oil, Japanese mint,cassia, caraway, cognac, jasmine, chamomile, menthol, ylang ylang, sage,fennel, pimenta, ginger, anise, coriander, coffee, liquorish, and mintoils from a species of the genus Mentha, and encapsulated flavors. Mintoils useful in particular embodiments of the oral product 110 includespearmint and peppermint. Synthetic flavorants can also be used. In somecases, a combination of flavorants can be combined to imitate a tobaccoflavor. The particular combination of flavorants can be selected fromthe flavorants that are generally recognized as safe (“GRAS”) in aparticular country, such as the United States. Flavorants can also beincluded in the oral product as encapsulated flavorants.

In some cases, the flavorants in the extrudate are limited to less than20 weight percent in sum. In some cases, the flavorants in the extrudateare limited to be less than 10 weight percent in sum. For example,certain flavorants can be included in the extrudate in amounts of about1 weight percent to 5 weight percent.

The extrudate may optionally include other additives. For example, theseadditives can include non-nicotine alkaloids, dietary minerals,vitamins, dietary supplements, therapeutic agents, and fillers. Forexample, suitable vitamins include vitamins A, B1, B2, B6, C, D2, D3, E,F, K, and P. For example, an extrudate can include C-vitamins withnicotine. Suitable dietary minerals include calcium (as carbonate,citrate, etc.) or magnesium (as oxide, etc.), chromium (usually aspicolinate), and iron (as bis-glycinate). One or more dietary mineralscould be included in an extrudate with or without the use of otheradditives. Other dietary supplements and/or therapeutic agents can alsobe included as additives.

In some cases, an oral product can be made to include a therapeuticagent that is preferable absorbed transbuccally. For example, sotherapeutic agents do not pass into the blood stream if they areswallowed. Exemplary therapeutic agents that can be included in anextrudate provided herein can include Gerd, Buprenorphin, Nitroglycerin,Diclofenac, Fentanyl, Carbamazepine, Galantamine, Acyclovir,Polyamidoamine Nanoparticles, Chlorpheniramine, Testosterone, Estradiol,Progesterone, Calcitonin, Fluorouracil, Naltrexone, Odansetron,Decitabine, Selegiline, Lamotrigine, and Prochlorperazine. For example,an oral product can include Buprenorphine and be used for paintreatment. In some cases, an oral product can include Nitroglycerin andbe used for Angina Pectoris treatment. Because of the release propertiesof the oral product, therapeutic agents included therein can be releasedat a rate such that a majority of the therapeutic agent is absorbedtransbuccally, rather than swallowed.

The extrudate can also include fillers such as starch, di-calciumphosphate, lactose, sorbitol, mannitol, and microcrystalline cellulose,calcium carbonate, dicalcium phosphate, calcium sulfate, clays, silica,glass particles, sodium lauryl sulfate (SLS), glyceryl palmitostearate,sodium benzoate, sodium stearyl fumarate, talc, and stearates (e.g., Mgor K), and waxes (e.g., glycerol monostearate, propylene glycolmonostearate, and acetylated monoglycerides), stabilizers (e.g.,ascorbic acid and monosterol citrate, BHT, or BHA), disintegratingagents (e.g., starch, sodium starch glycolate, cross caramellose, crosslinked PVP), pH stabilizers, or preservatives. In some cases, the amountof filler in the oral product 110 is limited to less than 10 weightpercent in sum. In some cases, the amount of filler in the extrudate islimited to be less than 5 weight percent in sum. In some cases, thefillers are mouth stable. In some cases, the fillers can dissolve ordisintegrate during use and thus result in an oral product that becomesmore pliable during use.

Fibers

The extrudate can include fibers within the mouth-stable polymer matrix.When in the oral product, the fibers can provide passages in themouth-stable polymer matrix, which can permit certain additives withinthe polymer matrix to be released into an oral cavity when the oralproduct is received in an oral cavity and exposed to saliva. The fiberscan be cellulosic fibers. The cellulosic fibers can be derived fromplant tissue. In some cases, the cellulosic fibers include cellulose.The cellulosic fibers can further include lignin and/or lipids. Suitablesources for cellulosic fibers include wood pulp, cotton, sugar beets,bran, citrus pulp fiber, switch grass and other grasses, Salix (willow),tea, and Populus (poplar). In some cases, the cellulosic fibers can bechopped or shredded plant tissue comprising various natural flavors,sweeteners, or active ingredients. In some cases, the oral product 110can include nicotine as an additive (optionally with additionalsweeteners and flavors) and non-tobacco cellulosic fiber, and thus besubstantially free of tobacco plant tissue.

The cellulosic fibers can have a variety of dimensions. The dimensionsof the fibers (in addition to the amount) can impact the releasecharacteristics of the additives. For example, cellulosic fibers can behydrophilic, thus water soluble additives (e.g., nicotine) canpreferentially be absorbed in fiber-polymer matrix. The release profileof nicotine from a polyurethane oral product can be impacted by both thefiber sizes and the amounts of fiber. In some cases, the cellulosicfiber can be processed to have an average fiber size of less than 200micrometers. In particular embodiments, the fibers are between 75 and125 micrometers. In some cases, the fibers are processed to have a sizeof 75 micrometers or less. In some cases, an oral product can includebetween 5 weight percent and 50 weight percent fiber.

The extrudate can also include soluble fibers. The soluble fibers can beadapted to dissolve when exposed to saliva when the oral product isreceived in an oral cavity. In some cases, the soluble fiber can be amaltodextrin. The maltodextrin can be derived from corn. For example,Soluble Dietary Fiber can be included in an extrudate. Soluble fiberscan be used alone or with cellulosic fibers to provide channels foradditives to be released from the oral product. As the soluble fibersdissolve, the oral product can become more flexible and the additionalchannels can open up to permit the release of additional additivedeposits. Suitable soluble fibers include psyllium fibers. In somecases, the fibers can be partially soluble. For example, sugar beetfibers can partially dissolve during use.

In some cases, an oral product 110 can include a combination of solubleand insoluble fibers. The ratio of soluble to insoluble fiber can impactthe softness of texture of the oral product. The ratio of soluble toinsoluble fiber can also impact the compressibility of the oral product.In some cases, a ratio of soluble to insoluble fiber is between 1:60 and60:1. In some cases, the ratio of soluble to insoluble fiber is greaterthan 1:50, greater than 1:40, greater than 1:30, greater than 1:20,greater than 1:10, or greater than 1:5. In some cases, the ratio ofsoluble to insoluble fiber is less than 1:1, less than 1:2, less than1:5, less than 1:10, less than 1:20, or less that 1:30. In some cases,an oral product having a mixture of soluble and insoluble fibers canhave a percentage of compression @ 250 N of between 60 percent and 98percent, between 65 percent and 95 percent, between 70 percent and 90percent, or between 80 and 89 percent.

Plasticizers

The extrudate can also include one or more plasticizers. Plasticizerscan soften the final oral product and thus increase its flexibility.Plasticizers work by embedding themselves between the chains ofpolymers, spacing them apart (increasing the “free volume”), and thussignificantly lowering the glass transition temperature for the plasticand making it softer. Suitable plasticizers include propylene glycol,glycerin, vegetable oil, and medium chain triglycerides. In some cases,the plasticizer can include phthalates. Esters of polycarboxylic acidswith linear or branched aliphatic alcohols of moderate chain length canalso be used as plasticizers. Moreover, plasticizers can facilitate theextrusion processes described below. In some cases, the extrudate caninclude up to 20 weight percent plasticizer. In some cases, theextrudate includes between 0.5 and 10 weight percent plasticizer, theextrudate can include between 1 and 8 weight percent plasticizer, orbetween 2 and 4 weight percent plasticizer. For example, an oral productcomprising a polyurethane polymer matrix and include about 3 to 6.5weight percent of propylene glycol.

Other Embodiments

It is to be understood that, while the invention has been describedherein in conjunction with a number of different aspects, the foregoingdescription of the various aspects is intended to illustrate and notlimit the scope of the invention, which is defined by the scope of theappended claims. Other aspects, advantages, and modifications are withinthe scope of the following claims.

Disclosed are methods and compositions that can be used for, can be usedin conjunction with, can be used in preparation for, or are products ofthe disclosed methods and compositions. These and other materials aredisclosed herein, and it is understood that combinations, subsets,interactions, groups, etc. of these methods and compositions aredisclosed. That is, while specific reference to each various individualand collective combinations and permutations of these compositions andmethods may not be explicitly disclosed, each is specificallycontemplated and described herein. For example, if a particularcomposition of matter or a particular method is disclosed and discussedand a number of compositions or methods are discussed, each and everycombination and permutation of the compositions and the methods arespecifically contemplated unless specifically indicated to the contrary.Likewise, any subset or combination of these is also specificallycontemplated and disclosed.

What is claimed is:
 1. A method of forming a plurality of oral productcomprising: a. gripping a rod of oral product material with a grippingdevice; b. indexing the rod forward to have a leading end of the rodabut a stop at a first location; c. cutting a leading portion of the rodto create an oral product; d. moving the stop to a second location toallow the oral product to fall; e. moving the stop back to the firstlocation; and f. repeating steps (b)-(e).
 2. The method of claim 1,wherein the gripping device releases the rod after cutting the leadingportion of the rod and grips the rod again before repeating steps(b)-(e).
 3. The method of claim 2, wherein the gripping device releasesthe rod at the same time that the stop is moved to the second locationand grips the rod again at the same time that the stop is moved back tothe first location.
 4. The method of claim 2, wherein the grippingdevice is indexed between a first gripping location and a secondgripping location to index the rod forward towards the stop at the firstlocation after cutting the leading portion of the rod.
 5. The method ofclaim 1, wherein the gripping device comprises two gripping rollers thatrotate to index the rod forward after cutting a leading portion of therod to create an oral product.
 6. The method of claim 1, wherein thestop pivots between the first location and the second location betweencutting steps.
 7. The method of claim 1, further comprising weighing oneor more oral products to determine if the oral products are within apredetermined weight range.
 8. The method of claim 7, further comprisingadjusting the first location for the stop based on the weights of one ormore oral products.
 9. The method of claim 7, wherein the one or moreoral products are weighed using a load cell positioned below the firstlocation, wherein the one or more oral products fall into the load cellafter being cut from the rod.
 10. The method of claim 7, furthercomprising moving oral products within a predetermined weight range to acollection location and oral products outside of the predeterminedweight range to a discard location.
 11. The method of claim 10, whereinthe oral products are moved to the collection location or the discardlocation by directing air towards the oral products.
 12. The method ofclaim 1, wherein cutting the rod does not significantly alter thecross-sectional shape of the oral products from that of the rod.
 13. Themethod of claim 1, rod is at a temperature of less than 50° C.
 14. Themethod of claim 1, wherein the rod comprises a mixture of polymer andone or more additives.
 15. The method of claim 14, wherein the rodcomprises polyurethane, cellulosic fibers, nicotine, sweeteners, andflavorants.
 16. A machine for forming a plurality of oral productscomprising: a. a cutting device adapted to cut through a rod comprisingplastic; b. a stop spaced from the cutting device, the stop beingadapted to be moved from a first location to a second location; c. agripping device adapted to hold and index a rod towards the stop; and d.a load cell positioned to receive oral products cut from a rod by thecutting device.
 17. The machine of claim 16, wherein the first locationof the stop is adjustable.
 18. The machine of claim 16, furthercomprising a programmable logic controller that sequences and controlsthe operation of the machine to grip a rod with the gripping device,index the rod to have a leading end of the rod abut the stop at thefirst location, cut a leading portion of the rod to create an oralproduct, move the stop from the first location to the second location toallow the oral product to drop to a load cell, and weigh the oralproduct using the load cell.
 19. The machine of claim 18, wherein theprogrammable logic controller is further adapted to determine if theoral product is within a predetermined weight range, transfer the oralproduct to a collection location or a discard location based on adetected weight, adjust first location of the stop based on a detectedweight of one or more oral products, or a combination thereof.
 20. Themachine of claim 16, further comprising an infeed tray to support therod.
 21. The machine of claim 16, wherein the gripping device comprisestwo gripping surfaces adapted to selectively engage and disengage a rodand an actuator adapted to index the gripping surfaces between a firstgripping location and a second gripping location.
 22. The machine ofclaim 16, wherein the gripping device comprises two gripping rollersthat are adapted to grip opposite sides of a rod and intermittentlyrotate to index the rod.
 23. The machine of claim 16, wherein thecutting device comprises a blade, a blade holder, a blade holder guide,and a blade actuator.
 24. The machine of claim 16, further comprising anactuator to move the stop between the first location and the secondlocation.
 25. The machine of claim 16, further comprising an air nozzlesystem to blow oral products off the load cell.
 26. The machine of claim16, wherein the load cell comprises a wheel having a plurality of spacedthrough bores, wherein one or more oral products fall into one or moreof the spaced through bores after being cut, and the wheel rotates tomove the one or more oral products in and out of the load cell.